What we do

The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).

Facilitate development and access to medicines

EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients.

The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved. For more information see:

They also underpin important decisions about medicines marketed in Europe, referred to EMA through referral procedures. EMA coordinates inspections in connection with the assessment of marketing-authorisation applications or matters referred to its committees.

Monitor the safety of medicines across their lifecycle

EMA continuously monitors and supervises the safety of medicines that have been authorised in the EU, to ensure that their benefits outweigh their risks. The Agency works by:

Provide information to healthcare professionals and patients

The Agency publishes clear and impartial information about medicines and their approved uses. This includes public versions of scientific assessment reports and summaries written in lay language. For more information see:

evaluate applications for the authorisation of clinical trials. The authorisation of clinical trials occurs at Member State level, although the Agency plays a key role in ensuring that the standards of good clinical practice are applied in cooperation with the Member States and manages a database of clinical trials carried out in the EU.

evaluate medical devices. Medical devices are regulated by national competent authorities in Europe. EMA is involved in the assessment of certain categories of medical devices. For more information, see Medical devices

evaluate food supplements and cosmetics. These substances are evaluated at national level;

carry out research or develop medicines. Pharmaceutical companies or other medicines developers carry out the research and development of medicines, who then submit the findings and test results for their products to the Agency for evaluation;

take decisions or have information on the price or availability of medicines. Decisions about price and reimbursement take place at the level of each Member State in the context of the national health system of that country. For more information, see Health-technology-assessment bodies;

control the advertising of medicines. The control of the advertising of non-prescription medicines in the EU is primarily conducted on a self-regulatory basis by industry bodies, supported by the statutory role of the national regulatory authorities in the Member States;

control or have information on pharmaceutical patents.Patents having effect in most European countries may be obtained either nationally, via national patent offices, or via a centralised process at the European Patent Office;

develop treatment guidelines. National governments or the health authorities of individual EU Member States develop guidelines for decisions regarding diagnosis, management, and treatment in specific areas of healthcare (sometimes known as clinical guidelines);

provide medical advice. Healthcare professionals can provide individual patients advice on medical conditions, treatments or side effects with a medicine;

Related content

From lab to patient: the journey of a centrally authorised medicine

This
booklet
describes the journey of a medicine for human use authorised via EMA, from initial research to discussions on patient access to medicines across the EU. This includes how EMA supports medicine development by providing scientific advice and how it assesses a medicine’s benefits and risks once it receives an application for marketing authorisation.